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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K093122
Device Name MBCP+
Applicant
BIOMATLANTE
5, RUE EDOUARD BELIN
ZA LES QUATRE NATIONS
VIGNEUX DE BRETAGNE,  FR 44360
Applicant Contact JEANNE CHAMOUSSET-ROMAN
Correspondent
BIOMATLANTE
5, RUE EDOUARD BELIN
ZA LES QUATRE NATIONS
VIGNEUX DE BRETAGNE,  FR 44360
Correspondent Contact JEANNE CHAMOUSSET-ROMAN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received10/02/2009
Decision Date 03/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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